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25291

Beschreibung

A Double Blind Sham Controlled Trial of tDCS in Treating Schizophrenia and Depression; ODM derived from: https://clinicaltrials.gov/show/NCT00481026

Link

https://clinicaltrials.gov/show/NCT00481026

Stichworte

Versionen (1)
  1. 31.08.17 31.08.17 -
Hochgeladen am

31. August 2017

DOI

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    Eligibility Schizophrenia NCT00481026

    Englisch

    Eligibility Schizophrenia NCT00481026

    1 Formulare  
    Inclusion Criteria
    Beschreibung

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    schizophrenia
    Beschreibung

    Schizophrenia

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0036341
    participants will be included if they:
    Beschreibung

    Study Subject Participation Status Inclusion

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C1512693
    1. are voluntary and competent to consent;
    Beschreibung

    Voluntary participation | Competence Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0680274
    UMLS CUI [2,1]
    C0086035
    UMLS CUI [2,2]
    C1511481
    2. have a diagnosis of schizophrenia or schizoaffective disorder as confirmed by the structure clinical interview for the dsm-iv (scid-iv)
    Beschreibung

    Schizophrenia | Schizoaffective Disorder

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0036341
    UMLS CUI [2]
    C0036337
    3. have persistent positive and negative symptoms despite having trialled, or being currently medicated, with antipsychotic medication; and
    Beschreibung

    Positive and negative symptoms persistent | Drug trial | Antipsychotic Agents

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0871099
    UMLS CUI [1,2]
    C0205322
    UMLS CUI [2]
    C0304229
    UMLS CUI [3]
    C0040615
    4. are between the ages of 18 and 65.
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    concomitant medications including:
    Beschreibung

    Pharmaceutical Preparations

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    1. benzodiazepines,
    Beschreibung

    Benzodiazepines

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005064
    2. mood stabilizers (lithium, valproic acid)
    Beschreibung

    Mood Stabilizers | Lithium | Valproic Acid

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C4020582
    UMLS CUI [2]
    C0023870
    UMLS CUI [3]
    C0042291
    3. antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. since carbamazepine has been shown to interfere with the effects of anodal tdcs, potential participants taking it will not be suitable for inclusion in the trial.
    Beschreibung

    Antidepressive Agents | Serotonin Uptake Inhibitors | Tricyclic Antidepressive Agents | Anticholinergic Agents | Carbamazepine Interferes with Anodal Transcranial Direct Current Stimulation Effects

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0003289
    UMLS CUI [2]
    C0162758
    UMLS CUI [3]
    C0003290
    UMLS CUI [4]
    C0242896
    UMLS CUI [5,1]
    C0006949
    UMLS CUI [5,2]
    C0521102
    UMLS CUI [5,3]
    C3850022
    UMLS CUI [5,4]
    C1280500
    depression
    Beschreibung

    Depressive disorder

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0011581
    participants will be included if they:
    Beschreibung

    Study Subject Participation Status Inclusion

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C1512693
    1. are competent to consent;
    Beschreibung

    Competence Consent

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0086035
    UMLS CUI [1,2]
    C1511481
    2. have a diagnosis of major depression and are currently experiencing a major depressive episode as confirmed by the structure clinical interview for the dsm-iv (scid-iv);
    Beschreibung

    Major Depressive Disorder | Major depressive episode

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C1269683
    UMLS CUI [2]
    C0024517
    3. are treatment resistant, defined as a failure to achieve a clinical response, or an inability to tolerate, an antidepressant trial of sufficient dose for at least 6 weeks; and
    Beschreibung

    Treatment Resistant Disorders | Absent response to treatment | Intolerance to Antidepressive Agents Dose

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0871547
    UMLS CUI [2]
    C0438286
    UMLS CUI [3,1]
    C1744706
    UMLS CUI [3,2]
    C0003289
    UMLS CUI [3,3]
    C0178602
    4. are between the ages of 18 and 75.
    Beschreibung

    Age

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    concomitant medications including:
    Beschreibung

    Pharmaceutical Preparations

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0013227
    1. benzodiazepines,
    Beschreibung

    Benzodiazepines

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0005064
    2. mood stabilizers (lithium, valproic acid)
    Beschreibung

    Mood Stabilizers | Lithium | Valproic Acid

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C4020582
    UMLS CUI [2]
    C0023870
    UMLS CUI [3]
    C0042291
    3. antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. since carbamazepine has been shown to interfere with the effects of anodal tdcs, potential participants taking it will not be suitable for inclusion in the trial.
    Beschreibung

    Antidepressive Agents | Serotonin Uptake Inhibitors | Tricyclic Antidepressive Agents | Anticholinergic Agents | Carbamazepine Interferes with Anodal Transcranial Direct Current Stimulation Effects

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0003289
    UMLS CUI [2]
    C0162758
    UMLS CUI [3]
    C0003290
    UMLS CUI [4]
    C0242896
    UMLS CUI [5,1]
    C0006949
    UMLS CUI [5,2]
    C0521102
    UMLS CUI [5,3]
    C3850022
    UMLS CUI [5,4]
    C1280500
    Exclusion Criteria
    Beschreibung

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    patients will be excluded if they:
    Beschreibung

    Study Subject Participation Status Exclusion

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C2348568
    UMLS CUI [1,2]
    C2828389
    1. have a dsm-iv history of substance abuse or dependence in the last 6 months;
    Beschreibung

    Substance Use Disorders | Substance Dependence

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0038586
    UMLS CUI [2]
    C0038580
    2. have a concomitant major and unstable medical or neurologic illness;
    Beschreibung

    Comorbidity Major Unstable | Nervous system disorder Major Unstable

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0009488
    UMLS CUI [1,2]
    C0205164
    UMLS CUI [1,3]
    C0443343
    UMLS CUI [2,1]
    C0027765
    UMLS CUI [2,2]
    C0205164
    UMLS CUI [2,3]
    C0443343
    3. are currently taking carbamazepine; or,
    Beschreibung

    Carbamazepine

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0006949
    4. are pregnant.
    Beschreibung

    Pregnancy

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0032961
    patients will be withdrawn from the study if they:
    Beschreibung

    Patient withdrawn from trial

    Datentyp

    boolean

    Alias
    UMLS CUI [1]
    C0422727
    1. withdraw consent;
    Beschreibung

    Consent Withdraw

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1511481
    UMLS CUI [1,2]
    C2349954
    2. experience significant clinical deterioration;
    Beschreibung

    Deterioration Clinical Significance

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C1279889
    UMLS CUI [1,2]
    C2826293
    3. fail to tolerate the procedure; or,
    Beschreibung

    Therapeutic procedure Receive failed

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0087111
    UMLS CUI [1,2]
    C1514756
    UMLS CUI [1,3]
    C0231175
    4. develop a serious adverse event. in the event that a patient is withdrawn or drops out of the study, efforts will be made to obtain a final set of clinical, cognitive and neurophysiological measures at the time of withdrawal for a last observation carried forward analysis.
    Beschreibung

    Adverse event Serious | Patient withdrawn from trial | Withdrawal by Subject | Interventional procedure Clinical | Interventional procedure Cognitive | Interventional procedure Neurophysiology

    Datentyp

    boolean

    Alias
    UMLS CUI [1,1]
    C0877248
    UMLS CUI [1,2]
    C0205404
    UMLS CUI [2]
    C0422727
    UMLS CUI [3]
    C1710677
    UMLS CUI [4,1]
    C0184661
    UMLS CUI [4,2]
    C0205210
    UMLS CUI [5,1]
    C0184661
    UMLS CUI [5,2]
    C1516691
    UMLS CUI [6,1]
    C0184661
    UMLS CUI [6,2]
    C0700630
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    Ähnliche Modelle

    Eligibility Schizophrenia NCT00481026

    1 Formulare
    Name
    Typ
    Description | Question | Decode (Coded Value)
    Datentyp
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Schizophrenia
    Item
    schizophrenia
    boolean
    C0036341 (UMLS CUI [1])
    Study Subject Participation Status Inclusion
    Item
    participants will be included if they:
    boolean
    C2348568 (UMLS CUI [1,1])
    C1512693 (UMLS CUI [1,2])
    Voluntary participation | Competence Consent
    Item
    1. are voluntary and competent to consent;
    boolean
    C0680274 (UMLS CUI [1])
    C0086035 (UMLS CUI [2,1])
    C1511481 (UMLS CUI [2,2])
    Schizophrenia | Schizoaffective Disorder
    Item
    2. have a diagnosis of schizophrenia or schizoaffective disorder as confirmed by the structure clinical interview for the dsm-iv (scid-iv)
    boolean
    C0036341 (UMLS CUI [1])
    C0036337 (UMLS CUI [2])
    Positive and negative symptoms persistent | Drug trial | Antipsychotic Agents
    Item
    3. have persistent positive and negative symptoms despite having trialled, or being currently medicated, with antipsychotic medication; and
    boolean
    C0871099 (UMLS CUI [1,1])
    C0205322 (UMLS CUI [1,2])
    C0304229 (UMLS CUI [2])
    C0040615 (UMLS CUI [3])
    Age
    Item
    4. are between the ages of 18 and 65.
    boolean
    C0001779 (UMLS CUI [1])
    Pharmaceutical Preparations
    Item
    concomitant medications including:
    boolean
    C0013227 (UMLS CUI [1])
    Benzodiazepines
    Item
    1. benzodiazepines,
    boolean
    C0005064 (UMLS CUI [1])
    Mood Stabilizers | Lithium | Valproic Acid
    Item
    2. mood stabilizers (lithium, valproic acid)
    boolean
    C4020582 (UMLS CUI [1])
    C0023870 (UMLS CUI [2])
    C0042291 (UMLS CUI [3])
    Antidepressive Agents | Serotonin Uptake Inhibitors | Tricyclic Antidepressive Agents | Anticholinergic Agents | Carbamazepine Interferes with Anodal Transcranial Direct Current Stimulation Effects
    Item
    3. antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. since carbamazepine has been shown to interfere with the effects of anodal tdcs, potential participants taking it will not be suitable for inclusion in the trial.
    boolean
    C0003289 (UMLS CUI [1])
    C0162758 (UMLS CUI [2])
    C0003290 (UMLS CUI [3])
    C0242896 (UMLS CUI [4])
    C0006949 (UMLS CUI [5,1])
    C0521102 (UMLS CUI [5,2])
    C3850022 (UMLS CUI [5,3])
    C1280500 (UMLS CUI [5,4])
    Depressive disorder
    Item
    depression
    boolean
    C0011581 (UMLS CUI [1])
    Study Subject Participation Status Inclusion
    Item
    participants will be included if they:
    boolean
    C2348568 (UMLS CUI [1,1])
    C1512693 (UMLS CUI [1,2])
    Competence Consent
    Item
    1. are competent to consent;
    boolean
    C0086035 (UMLS CUI [1,1])
    C1511481 (UMLS CUI [1,2])
    Major Depressive Disorder | Major depressive episode
    Item
    2. have a diagnosis of major depression and are currently experiencing a major depressive episode as confirmed by the structure clinical interview for the dsm-iv (scid-iv);
    boolean
    C1269683 (UMLS CUI [1])
    C0024517 (UMLS CUI [2])
    Treatment Resistant Disorders | Absent response to treatment | Intolerance to Antidepressive Agents Dose
    Item
    3. are treatment resistant, defined as a failure to achieve a clinical response, or an inability to tolerate, an antidepressant trial of sufficient dose for at least 6 weeks; and
    boolean
    C0871547 (UMLS CUI [1])
    C0438286 (UMLS CUI [2])
    C1744706 (UMLS CUI [3,1])
    C0003289 (UMLS CUI [3,2])
    C0178602 (UMLS CUI [3,3])
    Age
    Item
    4. are between the ages of 18 and 75.
    boolean
    C0001779 (UMLS CUI [1])
    Pharmaceutical Preparations
    Item
    concomitant medications including:
    boolean
    C0013227 (UMLS CUI [1])
    Benzodiazepines
    Item
    1. benzodiazepines,
    boolean
    C0005064 (UMLS CUI [1])
    Mood Stabilizers | Lithium | Valproic Acid
    Item
    2. mood stabilizers (lithium, valproic acid)
    boolean
    C4020582 (UMLS CUI [1])
    C0023870 (UMLS CUI [2])
    C0042291 (UMLS CUI [3])
    Antidepressive Agents | Serotonin Uptake Inhibitors | Tricyclic Antidepressive Agents | Anticholinergic Agents | Carbamazepine Interferes with Anodal Transcranial Direct Current Stimulation Effects
    Item
    3. antidepressants (including serotonin reuptake inhibitors and tricyclic antidepressants) and anticholinergics will be allowed. since carbamazepine has been shown to interfere with the effects of anodal tdcs, potential participants taking it will not be suitable for inclusion in the trial.
    boolean
    C0003289 (UMLS CUI [1])
    C0162758 (UMLS CUI [2])
    C0003290 (UMLS CUI [3])
    C0242896 (UMLS CUI [4])
    C0006949 (UMLS CUI [5,1])
    C0521102 (UMLS CUI [5,2])
    C3850022 (UMLS CUI [5,3])
    C1280500 (UMLS CUI [5,4])
    Item Group
    C0680251 (UMLS CUI)
    Study Subject Participation Status Exclusion
    Item
    patients will be excluded if they:
    boolean
    C2348568 (UMLS CUI [1,1])
    C2828389 (UMLS CUI [1,2])
    Substance Use Disorders | Substance Dependence
    Item
    1. have a dsm-iv history of substance abuse or dependence in the last 6 months;
    boolean
    C0038586 (UMLS CUI [1])
    C0038580 (UMLS CUI [2])
    Comorbidity Major Unstable | Nervous system disorder Major Unstable
    Item
    2. have a concomitant major and unstable medical or neurologic illness;
    boolean
    C0009488 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    C0443343 (UMLS CUI [1,3])
    C0027765 (UMLS CUI [2,1])
    C0205164 (UMLS CUI [2,2])
    C0443343 (UMLS CUI [2,3])
    Carbamazepine
    Item
    3. are currently taking carbamazepine; or,
    boolean
    C0006949 (UMLS CUI [1])
    Pregnancy
    Item
    4. are pregnant.
    boolean
    C0032961 (UMLS CUI [1])
    Patient withdrawn from trial
    Item
    patients will be withdrawn from the study if they:
    boolean
    C0422727 (UMLS CUI [1])
    Consent Withdraw
    Item
    1. withdraw consent;
    boolean
    C1511481 (UMLS CUI [1,1])
    C2349954 (UMLS CUI [1,2])
    Deterioration Clinical Significance
    Item
    2. experience significant clinical deterioration;
    boolean
    C1279889 (UMLS CUI [1,1])
    C2826293 (UMLS CUI [1,2])
    Therapeutic procedure Receive failed
    Item
    3. fail to tolerate the procedure; or,
    boolean
    C0087111 (UMLS CUI [1,1])
    C1514756 (UMLS CUI [1,2])
    C0231175 (UMLS CUI [1,3])
    Adverse event Serious | Patient withdrawn from trial | Withdrawal by Subject | Interventional procedure Clinical | Interventional procedure Cognitive | Interventional procedure Neurophysiology
    Item
    4. develop a serious adverse event. in the event that a patient is withdrawn or drops out of the study, efforts will be made to obtain a final set of clinical, cognitive and neurophysiological measures at the time of withdrawal for a last observation carried forward analysis.
    boolean
    C0877248 (UMLS CUI [1,1])
    C0205404 (UMLS CUI [1,2])
    C0422727 (UMLS CUI [2])
    C1710677 (UMLS CUI [3])
    C0184661 (UMLS CUI [4,1])
    C0205210 (UMLS CUI [4,2])
    C0184661 (UMLS CUI [5,1])
    C1516691 (UMLS CUI [5,2])
    C0184661 (UMLS CUI [6,1])
    C0700630 (UMLS CUI [6,2])
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